Antibiotics During Intrauterine Balloon Tamponade Placement
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Postpartum Endometritis
研究概览
简要总结
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
详细描述
The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade.
Patients who are candidates for study enrollment will be identified on Labor & Delivery or in the Maternal-Fetal Care Unit. Patients who give consent will be randomized by random number generator to receive either antibiotics (Group A) or no antibiotics (Group B).
If the patient is randomized to Group A, she will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
If the patient is randomized to Group B, she will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to give consent
- •Gestational age > 24 weeks
- •Postpartum
- •Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours
- •Primary obstetrician amenable to proceeding with either method of management during the study period.
排除标准
- •Age < 18 years old
- •IBT removed within 2 hours of placement
- •Chorioamnionitis
- •Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
研究组 & 干预措施
Antibiotics
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
干预措施: CeFAZolin 1000 MG (Drug)
Antibiotics
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
干预措施: Clindamycin 900 MG in 6 ML Injection (Drug)
结局指标
主要结局
Postpartum Endometritis
时间窗: 6 weeks
Number of participants with postpartum endometritis as defined by clinical documentation
次要结局
- Postpartum Hemoglobin(2 weeks)
- Blood Transfusion(2 weeks)
- EBL(2 weeks)
- Number of Participants With a Fever(6 weeks)
- Receiving Postpartum Antibiotics(6 weeks)
- Hysterectomy(6 weeks)
- Resource Utilization Measures(6 weeks)
- Maternal ICU Admission(6 weeks)
- Maternal Death(6 weeks)
- Hospital Readmission(6 weeks)
研究者
Kimberly Gregory
Director, Women's Reproductive Health Services
Cedars-Sinai Medical Center